About OssDsign/General Questions

Who are OssDsign?
OssDsign is an innovator, designer and manufacturer of implants and material technology for bone regeneration. We are surgeons, scientists and engineers - committed to improving outcomes in cranioplasty and facial reconstructive surgery.
What are the outcomes and clinical results observed in using OSSDSIGN® Cranial and OSSDSIGN® Facial?
Clinical experiences with OSSDSIGN® products have shown reduced rates of post-operative complications. Evidence of improved soft tissue healing and long-term bone regeneration has been published in peer reviewed journals. The clinical performance as well as further evidence of bone formation is currently being compiled for publication.
Where are the implants manufactured?
OssDsign has in-house manufacturing facility in Uppsala, Sweden.

Material

What does the ceramic material consist of?
The OSSDSIGN® material is a blend of Monetite, ß-tri calcium phosphate and ß-calcium pyrophosphate.
How chemically stable is the material composition?
When implanted, the OSSDSIGN® material is subject to the process of coupled bone formation. This process may vary between individuals due to differences in metabolic activity.
Does the implant produce image artifacts in MR?
The implant is MR Conditional. Please see the full Instructions for Use for further information.
Are the OSSDSIGN® products as mechanically strong as other products on the market?
An OSSDSIGN® Cranial implant can withstand at least the force of a standard titanium mesh before being deformed. The ceramic tiles of OSSDSIGN® Cranial are connected by a titanium skeleton. The titanium between the tiles have deformation zones. If the implant withstands an external load, the deformation zones will absorb a large part of the load. OSSDSIGN® Facial is also reinforced with similar non- exposed, high-strength titanium.

Use of OSSDSIGN® CRANIAL

What are the storage conditions?
Store between 4-35°C (40-95°F)
How is the implant sterilized and what is the shelf-life?
The sterilization method is steam sterilization (20 minutes, 121°C). The shelf-life is 1 year.
Can hospitals re-sterilize the implant, e.g. during surgery?
No, the implants should not be re-sterilized, for example during surgery
How is the implant fixated?
The implant is attached to surrounding bone with commercially available titanium screws. The fixation arm can be slightly bent for optimized fixation. More information on the surgical procedure can be found in the Instructions For Use.
Can the implant be soaked before implantation?
Yes, however there is no need to soak OSSDSIGN® Cranial implants before implantation.
Can I use locally administrated antibiotics together with the implant?
We are aware, that in certain patients thought to be at high risk of surgical site infections, Karolinska Hospital have pre-soaked implants with sterile NaCl solution with added Gentamycin.
Are there any specific considerations regarding wound closure and suturing?
A surgical incision directly above the implant increases the risk of wound dehiscence and subsequent infection and should be avoided if possible. If this approach can not be avoided, the use of vertical mattress suturing technique is recommended. https://www.youtube.com/watch?v=824FhFUJ6wc

Use of OSSDSIGN® FACIAL

What are the storage conditions?
Store between 4-35°C (40-95°F)
How is the implant sterilized and what is the shelf-life?
The sterilization method is steam sterilization (20 minutes, 121°C). The shelf-life is 1 year.
Can I use locally administrated antibiotics together with the implant?
We are aware, that in certain patients thought to be at high risk of surgical site infections, Karolinska Hospital have pre-soaked implants with sterile NaCl solution with added Gentamycin.

ORDERING/DESIGN/DELIVERY

How can I order cranial/facial implants?
Contact order@ossdsign.com or your local OssDsign representative and we will help you immediately.
When can I expect delivery?
Approximately 4 weeks after the design proposal has been approved.
What are the requirements for the CT scan before placing the order?
CT scanning guidelines are available for download at ossdsign.com/order. Please contact us for more information.
How do I upload the file into Sharefile? Which format should it have?
This is easy and information is available for download at LINK TO ORDER. Always feel free to email order@ossdsign.com or call +46 18 55 39 93 if you have any questions.
Can other types of images be used, e.g. MR?
No, CT according to scanning guidelines is the only option currently.
How does the web/Sharefile/Folder system work?
Once a new account has been created, information can be shared between OssDsign and the surgeon in a safe manner. The surgeon can upload CT images and OssDsign can share the design proposal and quotation.
What happens after an order request has been placed?
A price quote and a proposed implant design is sent to the ordering surgeon at the latest two working days after the order and CT documentation have been received at OssDsign.
How can the design proposal be visualized?
The proposed implant design can be visualized by a series of digital images showing the design solution from different angels. The surgeon can also view the proposal in 3D, which requires the latest version of Acrobat reader.
How is the implant delivered?
The implants are delivered in a sterile packaging together with an instructive photo of the specific case.